RT Journal Article
SR Electronic
A1 Minarik, Jiri
A1 Pour, Ludek
A1 Maisnar, Vladimir
A1 Spicka, Ivan
A1 Jungova, Alexandra
A1 Jelinek, Tomas
A1 Brozova, Lucie
A1 Krhovska, Petra
A1 Scudla, Vlastimil
A1 Hajek, Roman
T1 Single agent daratumumab in advanced multiple myeloma possesses significant efficacy even in an unselected "real-world" population
JF Biomedical papers
YR 2019
VO 163
IS 3
SP 279
OP 283
UL https://biomed.papers.upol.cz/artkey/bio-201903-0015.php
AB Objective: The treatment of relapsed and refractory multiple myeloma (RRMM) remains challenging. The outcomes in highly pretreated populations are unsatisfactory and there is urgent need for novel and safe therapeutic approaches. Recently, daratumumab has been approved for RRMM with promising results even in monotherapy. The aim of this study was to assess the efficacy of single agent daratumumab outside a clinical trial. Patients and Methods: 14 patients with RRMM and significant pretreatment (median 4.5 previous lines) entered a specific healthcare program and received treatment with single agent daratumumab. They were followed for therapeutic response based on IMWG criteria, and incidence of adverse events. The data were collected using the Registry of Monoclonal Gammopathies. Results: The overall response rate was 38.5%. 23.1% of patients reached very good partial response, 15.4% reached partial remission, 15.4% had minimal response, 38.5% had stable disease and 7.7% had progressive disease. The median progression free survival was 4.6 months and median overall survival was not achieved. The toxicities were mostly mild, only infectious complications and hematological toxicity reached grade III. Conclusion: We conclude that daratumumab has significant activity in highly pretreated RRMM even as a single agent, with an acceptable toxicity profile and survival impact.